MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number TABLETOP

Device Problems Use of Incorrect Control/Treatment Settings (1126); Improper or Incorrect Procedure or Method (2017); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

A customer reported that the intraocular eye pressure was not kept stable during a procedure.It was reported that "false settings" were activated by the surgeon and this caused the event.The case was completed by using the same system.There was no harm to the patient.Additional event details have been requested.

Manufacturer Narrative

After priming the surgeon complained that the eye pressure was not stable.The surgery was completed normally.The company service representative noted no adverse event occurred and no patient harm was reported.The company service representative reported that there was no malfunction.The event occurred due to abnormal use of the device and noted the intraocular pressure (iop) setting was activated by the surgeon and caused the event.The system was manufactured on july 12, 2011.Based on qa assessment, the product met specifications at the time of release.The surgeon completed a questionnaire.The date of the event was (b)(6) 2015.The patient was a (b)(6) old female.The patient¿s pre-existing ocular condition included a retinal detachment.The surgery was on the right eye with a pars plana vitrectomy (ppv), endolaser coagulation, and silicone oil tamponade planned.The surgeon described the event as unstable intraocular (iop) between 0mmhg and 100mmhg and changing every second.The iop was stable only after the air/fluid exchange and working under air (sic).The event duration was thirty (30) minutes.The patient was not hospitalized.There were no medications or therapies in use at the time of the event.No unplanned medical intervention was required to treat the event.The unplanned surgical intervention was completing the air/fluid exchange before the completing the whole vitreous removal.In the surgeon¿s opinion the device caused or contributed to the event.Intraocular surgery has always been recognized to induce substantial intra-ocular pressure (iop) fluctuations, this is true for both anterior (i.E.Cataract surgery) and posterior segment (i.E.Vitrectomy) surgeries.Acute ocular hypotony is common during many intraocular surgeries.Pars plana vitrectomy (ppv) differs from other intraocular surgical procedures in that the prolonged acute hypotony is not a predominant feature.Intra-operatively, maintenance of eye pressure is a balance between infusion (irrigation) and extrusion (aspiration) with both parameters actively controlled by the surgeon and with the advent of iop control features, supported by vitrectomy/phaco machines.Hypotony (<5mmhg) is in fact fairly common in eye surgery that most eye surgeons anticipate this to occur during surgery.Surgeons have been trained to recognize and mitigate this by adjustment of the previously mentioned parameters be it manually or through the machine to adapt to what is being performed during surgery.The operations manual notes the system is a closed loop system that adjusts iop.The iop control cannot replace the standard of care in judging iop intraoperatively.The surgeon must continue the common practice of informally judging the following: finger palpation on the globe, tactile feedback of the surgical instruments, retinal vessel perfusion/pulsations, and presence of corneal edema.If the surgeon believes the iop is not responding to the system settings and is dangerously high, the surgeon can do one or more of the following as they deem appropriate in this situation (with care to avoid sudden hypotony): close the infusion stopcock, pinch the infusion line, and/or remove the infusion line.Based on this description, a likely contributor to the reported event is inadvertent iop activation by the surgeon.This issue is unrelated to the system, and can be attributed to abnormal use.The root cause of the reported event can be attributed to improper use of the system by the customer.(b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5093804
• MDR Text Key: 26682241
• Report Number: 2028159-2015-08481
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other